Proposed Final Document: Guidelines on Development of GHWP Documents - Part 2 Structure and Drafting

Submitted by admin on Fri, 12/06/2024 - 13:25

After the receipt of comments from members and the review by the GHWP leadership, the Proposed Final Document: Guidelines on Development of GHWP Documents - Part 2 Structure and Drafting will be proceeded for endorsement at The GHWP 28th Annual Meeting.

Proposed Final Document: Guideline on development of GHWP Documents - Part 1 Procedure for development

Submitted by admin on Fri, 12/06/2024 - 13:25

After the receipt of comments from members and the review by the GHWP leadership, the Proposed Final Document: Guideline on development of GHWP Documents - Part 1 Procedure for development will be proceeded for endorsement at The GHWP 28th Annual Meeting.

Proposed Final Document: Guidance Document for Medical Device Organizations- Product Localisation for Manufacturing and Importation

Submitted by admin on Fri, 12/06/2024 - 11:41

After the receipt of comments from members and the review by the GHWP leadership, the Proposed Final Document: Guidance Document for Medical Device Organizations- Product Localisation for Manufacturing and Importation will be proceeded for endorsement at The GHWP 28th Annual Meet

Proposed Final Document: Comparison study of ISO 13485 vs. QMS requirements in GHWP member countries or regions

Submitted by admin on Fri, 12/06/2024 - 11:41

After the receipt of comments from members and the review by the GHWP leadership, the Proposed Final Document: Comparison study of ISO 13485 vs. QMS requirements in GHWP member countries or regions will be proceeded for endorsement at The GHWP 28th Annual Meeting.

Proposed Final Document: Software as a Medical Device (SaMD) Pre-Market Submission Requirement – Comparison of requirement from Key jurisdictions

Submitted by admin on Fri, 12/06/2024 - 11:40

After the receipt of comments from members and the review by the GHWP leadership, the Proposed Final Document: Software as a Medical Device (SaMD) Pre-Market Submission Requirement – Comparison of requirement from Key jurisdictions will be proceeded for endorsement a